Amendment of regulation 177 (application of Part and interpretation)
139.—(1) Regulation 177(1) is amended as follows.
(2) In paragraph (1)—
(a)for “Schedule 33”, substitute “Schedules 12A and 33”;
(b)omit “, except to the extent set out in paragraph (4)(b),”;
(c)in sub-paragraph (a), at the end insert “or”;
(d)omit sub-paragraph (c) (and “or” immediately preceding it).
(3) In paragraph (2)—
(a)after “this Part” insert “and Schedule 12A”;
(b)in sub-paragraph (a), insert “or” at the end;
(c)omit sub-paragraph (c) (and “or” immediately preceding it).
(4) In paragraph (3)—
(a)for “Schedule 33” substitute “Schedules 12A and 33”;
(b)in sub-paragraph (a), at the end insert “or”;
(c)omit sub-paragraph (c) (and “or” immediately preceding it).
(5) Omit paragraph (4).
(6) In paragraph (5), omit the definitions of “co-ordination group”, “Eudravigilance database”, “Implementing Regulation” and “relevant competent authorities”.
Regulation 177 was amended by S.I. 2013/1855 and 2014/1878.